Throughout the years the medical field has utilized various techniques in an effort to join or bond body tissue together. Historically, suturing was the accepted technique for rejoining severed tissues and closing wounds. Suturing is achieved with a surgical needle and a suturing thread, with the intended function of sutures to hold the edges of a wound or tissue against one another during the healing process. Staples are used to replace suturing when joining or anastomosing various body structures, such as, for example, the bowel. The surgical stapling devices employed to apply staples are generally designed to simultaneously cut and seal an extended segment of tissue in a patient.
Linear or annular/circular surgical stapling devices are employed by surgeons to sequentially or simultaneously apply one or more rows of surgical fasteners, e.g., staples, to body tissue for the purpose of joining segments of body tissue together and/or for the creation of an anastomosis. Linear surgical stapling devices generally include a pair of jaws or finger-like structures between which body tissue to be joined is placed. When the surgical stapling device is actuated, firing bars move longitudinally and contact staple drive members in one of the jaws, and surgical staples are pushed through the body tissue and into and against an anvil in the opposite jaw thereby crimping the staples closed. A knife blade may be provided to cut between the rows/lines of staples.
Annular or circular surgical stapling devices generally include an annular staple cartridge assembly including a plurality of annular rows of staples (typically two or three), an anvil assembly operatively associated with the annular cartridge assembly, and an annular blade disposed internal of the rows of staples. In general, an end-to-end anastomosis stapler typically places an array or group of staples into the approximated sections of a patient's bowels or other tubular organs. The resulting anastomosis contains an inverted section of bowel which contains numerous “B” shaped staples to maintain a secure connection between the approximated sections of bowel.
Anastomotic leaks may result in significant morbidity and frequently death. In addition to the use of surgical staples, sealants, e.g., synthetic or biological sealants, can be applied to the surgical site to guard against leakage. The biological sealants are typically applied to the outer surface of the anastomosis in a separate step.
U.S. Pat. No. 7,645,288 “Anastomotic ring applier with inflatable members”, assigned to ETHICON ENDO SURGERY INC. describes a surgical instrument comprises a handle connected to a shaft and a pair of inflatable members. The shaft includes conduits for communicating a pressurized medium to the inflatable members and an insufflation tube. The handle includes a port for communicating a pressurized medium to the conduits and a port for communicating a pressurized medium to the insufflation tube. After an anastomotic ring has been deployed, the shaft may be positioned such that an inflatable member is positioned within each of the lumens joined by the anastomosis, such that an inflatable member is located on each side of the anastomosis. The inflatable members may be inflated to provide a seal in each of the lumens. With each of the lumens sealed by the inflatable members, the anastomosis site may be insufflated through the insufflation tube to leak or pressure test the anastomosis.
According to the cited patent, a surgical instrument operable to test an anastomosis, wherein the anastomosis is located at an anastomosis site in a patient, the instrument comprising: (a) a handle; (b) a tip; (c) a tip actuator, wherein the tip actuator is configured to move the tip from a retracted position to an extended position; (d) a shaft connected to the handle, the shaft comprising: (i) an outer surface, (ii) a proximal end, wherein the handle is located at the proximal end of the shaft, (iii) a distal end, wherein the distal end of the shaft comprises two or more inflatable members adjacent the outer surface, wherein the two or more inflatable members are spaced to permit at least one inflatable member of the two or more inflatable members to be positioned on a first side of the anastomosis and another at least one inflatable member of the two or more inflatable members to be positioned on a second side of the anastomosis, wherein the at least one inflatable member is configured to provide a seal of at least one of the one or more lumens, wherein the seal is adjacent the anastomosis, wherein the seal is provided upon inflation of the at least one inflatable member, (iv) one or more conduits configured to communicate a pressurized medium to at least one of the two or more inflatable members, and (v) a tubular sheath, wherein the tubular sheath is moveable from a first position to a second position; (e) a ring deployment mechanism located at the distal end of the shaft adjacent the two or more inflatable members, wherein the ring deployment mechanism is operable to deploy an anastomotic ring at the anastomosis site, wherein the ring deployment mechanism defines a longitudinal axis, wherein the ring deployment mechanism comprises: (i) a proximal ring situated about said longitudinal axis, (ii) a first plurality of fingers, wherein each finger of the first plurality of fingers comprises a proximal segment and a distal segment, wherein the proximal segment of each finger of the first plurality of fingers is hingedly connected to the corresponding distal segment of the same finger of the first plurality of fingers at a corresponding finger joint, wherein the proximal segment of each finger of the first plurality of fingers is further hingedly connected to said proximal ring, wherein the first plurality of fingers are configured to engage the anastomotic ring at regions adjacent to the finger joints of the first plurality of fingers, (iii) a distal ring situated about said longitudinal axis, (iv) a second plurality of fingers, wherein each finger of the second plurality of fingers comprises a proximal segment and a distal segment, wherein the proximal segment of each finger of the second plurality of fingers is hingedly connected to the corresponding distal segment of the same finger of the second plurality of fingers at a corresponding finger joint, wherein the distal segment of each finger of the second plurality of fingers is further hingedly connected to said distal ring, wherein the second plurality of fingers are configured to engage the anastomotic ring at regions adjacent to the finger joints of the second plurality of fingers, and (v) a middle ring positioned in between said proximal ring and said distal ring, wherein the distal segment of each finger of the first plurality of fingers is further hingedly connected to the middle ring, wherein the proximal segment of each finger of the second plurality of fingers is further hingedly connected to the middle ring, wherein the middle ring longitudinally separates the distal segments of the first plurality of fingers from the proximal segments of the second plurality of fingers; (f) one or more actuators operable to actuate the ring deployment mechanism, wherein the one or more actuators is configured to move along the handle or the shaft; and (g) a tip tube positioned within the shaft, wherein the tip tube has a proximal end and a distal end, wherein the proximal end of the tip tube is coupled with the tip actuator, wherein the distal end of the tip tube is coupled with the tip, wherein the tip actuator is operable to move the tip from a retracted position relative to the tubular sheath to an extended position relative to the tubular sheath via the tip tube; wherein the tip is configured to cover a distal portion of the ring deployment mechanism when the tip is in the retracted position; wherein the tip is configured to uncover the distal portion of the ring deployment mechanism when the tip is in the extended position; wherein the tubular sheath is configured to cover a proximal portion of the ring deployment mechanism when the tubular sheath is in the first position; wherein the tubular sheath is configured to uncover the proximal portion of the ring deployment mechanism when the tubular sheath is in the second position.
As stated in the cited reference, the inflatable members may be inflated to provide a seal in each of the lumens, with each of the lumens sealed by the inflatable members, the anastomosis site may be insufflated through the insufflation tube to leak or pressure test the anastomosis.
European Patent Application publication No. EP2139406A1 or WO2008135083 “AN ANASTOMOTIC APPLIER AND METHOD FOR PERFORMING ENDOLUMENAL AND/OR TRANSLUMINAL ANASTOMOSIS”, assigned to ETHICON ENDO SURGERY INC., discloses an anastomotic ring applier system for deploying a first compression ring and a second compression ring, comprising an anastomotic applier including: a second ring carrier adapted to hold the second compression ring; a ring approximation device with a first portion connectable to an external first ring carrier device which supports said first compression ring and a second portion connected to said second ring carrier device, wherein the first portion forms a first thread and the second portion forms a second thread meshing the first thread; a rotary device acting on at least one of said first and second portions and configured to rotate the first and second portions to one another so that they translate to one another to approximate and interconnect the compression rings. The reference further discloses that the anastomotic ring applier system further includes a coupling device which comprises: a coupling portion connected to the first ring carrier and having an inflatable anchoring head, a catching portion connected to the ring approximation device and defining a receiving space for receiving at least part of the anchoring head and an access aperture through which the anchoring head is insertable from outside the catching portion into the receiving space, an activating device connected to the anchoring head and configured to deform the anchoring head such that it can take on an expanded configuration and a retracted configuration, wherein the access aperture is configured to allow insertion and withdrawal of the anchoring head when it is retracted and to lock the at least partially inserted anchoring head to the catching portion when it is expanded such as to firmly couple the approximation device to the first ring carrier device.
Various compression anastomotic ring systems have been pursued as a replacement to the staple-based anastomotic closure. For example, LARA™ compression anastomotic ring system developed by novoGI™ utilizes nitinol-based compression ring specifically targeting low anterior resection (LAR) procedures.
U.S. Pat. No. 7,527,185 “Compression anastomosis ring assembly and applicator for use therewith” assigned to Niti Surgical Solutions Ltd., discloses a compression anastomosis ring (CAR) assembly which comprises: a first portion which comprises: an anvil ring; and a second portion which comprises: a bottom ring positioned substantially parallel to and spaced apart from said anvil ring, said anvil ring and said bottom ring being adapted to be brought together in the presence of a closure force applied there across: at least one ring element, where one of said at least one ring elements is a needle ring positioned on a side of said bottom ring distal from said anvil ring, said needle ring having a plurality of needles extending generally transversely therefrom toward said first portion; and at least one spring element which provides a restorative force formed at least partially of a shape-memory alloy, said spring element positioned on one of said at least one ring elements and being in compressive force transmissive contact with said bottom ring, and wherein when said compression anastomosis ring (CAR) assembly is positioned so as to hold between said anvil ring and said bottom ring tissue portions to be compressed and joined by anastomosis, said needle ring is operative, in response to the closure force to drive said plurality of needles through the tissue portions to be compressed and to anchor said plurality of needles in said anvil ring, and wherein when said anvil ring and said bottom ring are brought together in the presence of the closure force holding the tissue portions therebetween, and when said anvil ring is anchored by said plurality of needles, the restorative force provided by said at least one spring element is operative on said bottom ring to compress said tissue portions thereby effecting anastomosis.
U.S. Pat. No. 5,250,058 “Absorbable anastomosic fastener means” assigned to ETHICON INC., discloses a mechanism which is capable of anastomosis of two lumens by an absorbable fastener. The fastener is made from two washer-like plates. One such plate has holes to receive latching prongs protruding from the other plate. Fastening is done through a single linear motion that causes the prongs to pierce the tissue, latches the prongs into a receiver and causes a knife blade to cut through excess fastener material and tissue. The ease of removal, by pulling the mechanism through the formed anastomosis, is greatly enhanced. The system can be used such that the plates can be placed in any configuration to properly anastomose tissue. The patent discloses a compression anastomosis device comprising: a piercing ring containing a plurality of piercing flanges; a receiving ring containing a plurality of receiving slots corresponding to said flanges; and spring means placed between said piercing and receiving rings to exert a spring force on one of said piercing and receiving rings.
Post-operative leakage of the stapled tissue seals, including anastomotic seals has been shown to lead to morbidity and mortality. A number of technologies are related to direct application of material to the serosal layer after stapling by either dripping or spraying. The problems associated with these techniques are that access is very difficult and visual assessment as to whether or not the material was applied to the right spot and completely around the anastomosis. The material is also applied on top of the serosal layer when the target site is actually subserosal along the staple line. Applying a therapeutic agent to the serosal layer of the colon requires the material to migrate through the serosa and to the staple region, then provide a biological affect, and overcome the problems associated with a leak formation, all within 24-48 hours, assuming the material was applied to the correct spot intra operatively. One of the most challenging steps in the application of a topical adjunctive therapy to a colorectal anastomosis is to provide the material to the site because of the extreme limitation in access to the site. Some colorectal anastomoses are performed relatively “low” in a patient (i.e. lower anterior resection) and the actual staple line is deep within the pelvic canal, which makes a topical application of material around the circumference very difficult.
The known compression anastomotic rings lack the reliability of stapled anastomosis. The staple based anastomotic joining is a widely accepted practice but there is a need in improving the technology to prevent post-operative leakage of the stapled tissue seals to improve the viability of the tissue joined by staples.